Abstracts tagged "clinical trial"

Abstract Number: 2576 • ACR Convergence 2023
Rapid Onset of Response in Adult Dermatomyositis Patients Receiving Anti-interferon β (PF-06823859): Results of a Phase 2, Double-blind, Randomized, Placebo-Controlled Study
Rohit Aggarwal¹, Elena Peeva², Aaron Mangold³, Abigail Sloan² and Myron Chu², ¹University of Pittsburgh, Pittsburgh, PA, ²Pfizer, Cambridge, MA, ³Mayo Clinic, Scottsdale, AZ
Background/Purpose: Interferon (IFN) dysregulation is a key feature in the pathogenesis of Dermatomyositis (DM). PF-06823859 is a potent, selective, humanized IgG1 neutralizing antibody directed against…
Abstract Number: 0183 • ACR Convergence 2023
Barriers and Facilitators to Recruiting Underrepresented Participants for Clinical Trials: Insights from the Lupus Clinical Investigators Network (LuCIN)
Tessa Englund¹, Christine Lee², Julie Hsieh², Richardae Araojo², Julia Mariano¹, Emily McCormick³, Stacie Bell⁴, Albert Roy⁵ and Saira Sheikh¹, ¹University of North Carolina at Chapel Hill, Chapel Hill, NC, ²U.S. Food and Drug Administration, Silver Spring, MD, ³Thurston Arthritis Research Center, Chapel Hill, NC, ⁴Lupus Therapeutics, Lakewood, CO, ⁵Lupus Research Alliance, New York, NY
Background/Purpose: Despite greater prevalence of lupus among diverse, racial and ethnic minority populations, marked gaps exist between populations affected by lupus and those enrolled in…
Abstract Number: 0519 • ACR Convergence 2023
Long-Term Safety and Efficacy of Bimekizumab in Patients with Active Ankylosing Spondylitis: 5-Year Results from a Phase 2b Study and Its Open-Label Extension
Atul Deodhar¹, Victoria Navarro-Compán², Denis Poddubnyy³, Lianne Gensler⁴, Sofia Ramiro⁵, Tetsuya Tomita⁶, Helena Marzo-Ortega⁷, Carmen Fleurinck⁸, Thomas Vaux⁹, Ute Massow¹⁰, Désirée van der Heijde⁵ and Xenofon Baraliakos¹¹, ¹Division of Arthritis and Rheumatic Disease, Oregon Health & Science University, Portland, OR, ²Department of Rheumatology, La Paz University Hospital, IdiPaz, Madrid, Spain, ³Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité – Universitätsmedizin Berlin, Berlin, Germany, ⁴University of California San Francisco, Department of Medicine, Division of Rheumatology, San Francisco, CA, ⁵Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ⁶Graduate School of Health Science, Morinomiya University of Medical Science, Osaka, Japan, ⁷NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ⁸UCB Pharma, Oosterzele, Belgium, ⁹UCB Pharma, Slough, United Kingdom, ¹⁰UCB Pharma, Monheim am Rhein, Germany, ¹¹Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany
Background/Purpose: Bimekizumab (BKZ), a monoclonal IgG1 antibody, selectively inhibits IL-17F in addition to IL17A. BKZ has demonstrated clinical efficacy and safety up to 3 years…
Abstract Number: 0820 • ACR Convergence 2023
Radiographic and Pain Outcomes from a Phase 3 Extension Study Evaluating the Safety and Efficacy of Lorecivivint in Subjects with Severe Osteoarthritis of the Knee (OA-07): 36 Month Single Blind and Placebo Crossover Phase Results
Yusuf Yazici¹, Christopher Swearingen², Victor Lopez³, Jon Britt⁴, Sarah Kennedy⁵, Jeyanesh Tambiah² and Timothy McAlindon⁶, ¹NYU Grossman School of Medicine, La Jolla, CA, ²Biosplice Therapeutics, Inc., San Diego, CA, ³Biosplice Therapeutics, Inc., Santa Clarita, CA, ⁴Biosplice Therapeutics, Inc., Los Angeles, CA, ⁵Biosplice Therapeutics, Inc., Superior, CO, ⁶Tufts Medical Center, Arlington, MA
Background/Purpose: Knee osteoarthritis (OA) has unmet need for safe, efficacious symptom and disease-modifying treatments. Lorecivivint (LOR), an intra-articular (IA) CLK/DYRK inhibitor thought to modulate Wnt…
Abstract Number: 1323 • ACR Convergence 2023
Distinct Treatment Responses in Patients with Rheumatoid Arthritis Receiving Filgotinib 200 Mg over 12 Months: A Post Hoc Analysis of FINCH 1
Peter C. Taylor¹, Yoshiya Tanaka², Emily Aiello³, Thomas P.A. Debray⁴, Chris Watson⁵, Kristina Harris⁶ and Gerd Burmester⁷, ¹Nuffield Department of Orthopedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom, ²University of Occupational and Environmental Health, Kitakyushu, Japan, ³Real-world Analytics, Cytel, Toronto, ON, Canada, ⁴Biostatistics, Galapagos NV, Mechelen, Belgium, ⁵Medical Affairs, Galapagos Biotech Ltd., Cambridge, United Kingdom, ⁶Medical Safety, Galapagos NV, Mechelen, Belgium, ⁷Charité – Universitätsmedizin Berlin, Department of Rheumatology and Clinical Immunology, Berlin, Germany
Background/Purpose: FINCH 1 (NCT02889796) was a Phase 3 randomized controlled trial evaluating filgotinib (FIL) in patients with rheumatoid arthritis and an inadequate response to methotrexate…
Abstract Number: 1440 • ACR Convergence 2023
Removal of Methotrexate in Patients with Active Psoriatic Arthritis with Newly Induced Ustekinumab Treatment Leads to a Delayed Response in DAPSA and DAS28 Within the First 16 Weeks
Michaela Koehm¹, Ann Christina Foldenauer², Tanja Rossmanith², Herbert Kellner³, Uta Kiltz⁴, Arnd Kleyer⁵, Gerd Burmester⁶, David Kofler⁷, Jan Brandt-Juergens⁸, Raoul Bergner⁹ and Frank Behrens¹⁰, ¹University Hospital Frankfurt, Frankfurt, Germany, ²Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Fraunhofer Cluster of Excellence Immune Mediated Diseases CIMD, Frankfurt, Germany, ³Hospital Neuwittelsbach, Center for Rheumatology and Gastroenterology, Munich, Germany, ⁴Rheumazentrum Ruhrgebiet, Herne, Germany, ⁵University Hospital Erlangen, Erlangen, Germany, ⁶Charité – Universitätsmedizin Berlin, Department of Rheumatology and Clinical Immunology, Berlin, Germany, ⁷University of Cologne, Cologne, Germany, ⁸rheumatologische Schwerpunktpraxis, Berlin, Germany, ⁹Municipal Hospital Ludwigshafen, Department of Internal Medicine A, Nephrology and Rheumatology, Ludwigshafen, Germany, ¹⁰Goethe-University & Fraunhofer ITMP, Frankfurt, Germany
Background/Purpose: Methotrexate (MTX) is often used as first-line DMARD therapy in active psoriatic arthritis (PsA). The value of MTX in combination with different bDMARDs is…
Abstract Number: 1687 • ACR Convergence 2023
Sex of the Patient Affects Response to Advanced Therapies in Psoriatic Arthritis: Meta-analysis of Data from Randomized Controlled Trials
Lihi Eder¹, Sivakami Mylvaganam², Jordi Pardo Pardo³, Jennifer Petkovic⁴, Vibeke Strand⁵, Philip J. Mease⁶ and Keith Colaco⁷, ¹Women’s College Research Institute, Division of Rheumatology, University of Toronto, Toronto, ON, Canada, ²Department of Biochemistry, University of Toronto, Toronto, ON, Canada, ³Cochrane Musculoskeletal, University of Ottawa, Ottawa, ON, Canada, ⁴Cochrane Equity Methods Group, University of Ottawa, Ottawa, ON, Canada, ⁵Stanford University, Portola Valley, CA, ⁶Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, WA, ⁷Women’s College Research Institute / Department of Health and Society, University of Toronto, Toronto, ON, Canada
Background/Purpose: Limited information exists on participation and study outcomes by sex in randomized controlled trials (RCTs) among patients with psoriatic arthritis (PsA). Through a systematic…
Abstract Number: 2143 • ACR Convergence 2023
Efficacy of Filgotinib in Patients with Rheumatoid Arthritis: Week 156 Results from a Long-term Extension Study
Maya Buch¹, Daniel Aletaha², Roberto F. Caporali³, Bernard G. Combe⁴, Hendrik Schulze-Koops⁵, Jacques-Eric Gottenberg⁶, Yoshiya Tanaka⁷, Ricardo Blanco⁸, Tsutomu Takeuchi⁹, Edmund V. Ekoka Omoruyi¹⁰, Katrien Van Beneden¹¹, Vijay Rajendran¹², Chris Watson¹³, Francesco De Leonardis¹⁴ and Paul Emery¹⁵, ¹University of Manchester and NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom, ²Division of Rheumatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria, Wien, Austria, ³Department of Clinical Sciences and Community Health, University of Milan, and Department of Rheumatology and Medical Sciences, ASST Gaetano Pini-CTO, Milano, Italy, ⁴Department of Rheumatology, Montpellier University, Montpellier, France, ⁵Division of Rheumatology and Clinical Immunology, Department of Internal Medicine IV, Ludwig-Maximilians–University Munich, Munich, Germany, ⁶Rheumatology Department, Strasbourg University Hospital, Strasbourg, France, ⁷University of Occupational and Environmental Health, Kitakyushu, Japan, ⁸Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain, ⁹Keio University School of Medicine and Saitama Medical University, Tokyo, Japan, ¹⁰Biostatistics, Galapagos NV, Mechelen, Belgium, ¹¹Medical Safety, Galapagos NV, Mechelen, Belgium, ¹²Clinical Research, Galapagos NV, Mechelen, Belgium, ¹³Medical Affairs, Galapagos Biotech Ltd., Cambridge, United Kingdom, ¹⁴Medical Affairs, Galapagos GmbH, Basel, Switzerland, ¹⁵Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom
Background/Purpose: In the treatment of RA, JAK inhibitors are a valuable option to meet remission or low disease activity (LDA) treatment targets following an inadequate…
Abstract Number: 2334 • ACR Convergence 2023
Remission Attainment in Patients with Systemic Lupus Erythematosus Treated with Anifrolumab Compared with Placebo over a 4-Year Period
Ronald van Vollenhoven¹, Eric Morand², Richard A. Furie³, Kenneth Kalunian⁴, Raj Tummala⁵, Gabriel Abreu⁶, Hussein Al-Mossawi⁷ and Catharina Lindholm⁶, ¹Amsterdam University Medical Centers, Amsterdam, Netherlands, ²Monash University, Centre for Inflammatory Diseases, Melbourne, Australia, ³Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, ⁴University of California San Diego, La Jolla, CA, ⁵BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, ⁶BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ⁷BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom
Background/Purpose: In patients with SLE, remission is an established therapeutic goal associated with reduced damage accrual and flares, and improved health-related quality of life.1 Here,…
Abstract Number: 2593 • ACR Convergence 2023
FT011 for the Treatment of Systemic Sclerosis. Results from a Phase II Study
Christopher Denton¹, Wendy Stevens², Nicole Kruger³, Michelle Papadimitriou⁴, Fay Khong⁴, Michelle Bradney³, Darren Kelly⁴ and Robert Lafyatis⁵, ¹University College London, London, United Kingdom, ²Department of Rheumatology, St Vincent's Hospital Melbourne, Fitzroy, Australia, ³Certa Therapeutics, Melbourne, Australia, ⁴Certa Therapeutics and Melbourne University, Melbourne, Australia, ⁵University of Pittsburgh, Pittsburgh, PA
Background/Purpose: Systemic Sclerosis (SSc) is an autoimmune disease characterized by vascular damage, inflammation, and fibrosis of the skin and organs, with no approved disease modifying…
Abstract Number: 0244 • ACR Convergence 2023
Efficacy and Safety of AR882, a Selective Uric Acid Transporter 1 (URAT1) Inhibitor, in Gout Patients with Various Baseline Characteristics Following 12-Week Treatment in Patients
James Cheng-Chung Wei¹, Roy Fleischmann², sarah Morris³, Vijay Hingorani⁴, Elizabeth Polvent⁵, Zancong Shen⁶, Shunqi Yan⁷, Li-Tain Yeh⁸ and Robert Keenan⁹, ¹Chung Shan Medical University Hospital, Department of Rheumatology, Taichung, Taiwan, ²Division of Rheumatology, University of Texas Southwestern Medical Center, Metroplex Clinical Research Center, Dallas, TX, ³Arthrosi Therapeutics Inc, San Diego, CA, ⁴Vanguard Healthsciences, Inc., San Diego, CA, ⁵Arthrosi Therapeutics, Inc., Roseville, CA, ⁶Arthrosi Therapeutics, San Diego, CA, ⁷Arthrosi Therapeutics, Inc., Laguna Hills, CA, ⁸Arthrosi Therapeutics, Inc., Irvine, CA, ⁹Arthrosi Therapeutics, Chapel Hill, NC
Background/Purpose: AR882 is a novel, potent, and selective URAT1inhibitor in development for the treatment of gout and tophaceous gout. AR882-202 was a global, multi-center, randomized,…
Abstract Number: 0523 • ACR Convergence 2023
Bimekizumab Maintained Stringent Clinical Responses Through Week 52 in Patients with Axial Spondyloarthritis: Results from Two Phase 3 Studies
Fabian Proft¹, Désirée van der Heijde², Xenofon Baraliakos³, Joerg Ermann⁴, Carmen Fleurinck⁵, Ute Massow⁶, Natasha De Peyrecave⁷, Vanessa Taieb⁸, Astrid van Tubergen⁹ and Victoria Navarro-Compán¹⁰, ¹Department of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany, ²Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ³Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany, ⁴Division of Rheumatology, Inflammation and Immunity, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, ⁵UCB Pharma, Oosterzele, Belgium, ⁶UCB Pharma, Monheim am Rhein, Germany, ⁷UCB Pharma, Brussels, Belgium, ⁸UCB Pharma, Colombes, France, ⁹Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Centre, Maastricht, Netherlands, ¹⁰Department of Rheumatology, La Paz University Hospital, IdiPaz, Madrid, Spain
Background/Purpose: Axial spondyloarthritis (axSpA) is a chronic rheumatic disease which requires optimal management and disease control. Patients (pts) can experience loss of response in the…
Abstract Number: 0821 • ACR Convergence 2023
Effects of Sprifermin on a Novel Outcome of Osteoarthritis Symptom Progression: Post Hoc Analysis of the FORWARD Study
Philip Conaghan¹, Nathaniel Katz², david Hunter³, Marc Hochberg⁴, Ali Guermazi⁵, Kenneth Somberg⁶, Julia Clive⁶, Mary Johnson⁶ and Niti Goel⁷, ¹University of Leeds, Leeds, United Kingdom, ²Tufts University and Ein Sof Innovation, Boston, MA, ³Sydney Musculoskeletal Health, University of Sydney, St. Leonards, Australia, ⁴University of Maryland School of Medicine, Baltimore, MD, ⁵Boston University, Boston, MA, ⁶TrialSpark, New York, NY, ⁷TrialSpark, Duke University, Durham, NC
Background/Purpose: People with knee OA (KOA) desire therapies which delay or reverse disease progression supporting the need for disease-modifying OA drugs (DMOADs). Sprifermin, truncated recombinant…
Abstract Number: 1325 • ACR Convergence 2023
Integrated Safety Analysis of Filgotinib in Patients with Moderate to Severe Active Rheumatoid Arthritis with a Maximum Exposure of 8.3 Years
Kevin Withrop¹, Daniel Aletaha², Roberto F. Caporali³, Yoshiya Tanaka⁴, Tsutomu Takeuchi⁵, Paul Van Hoek⁶, Pieter-Jan Stiers⁷, Vijay Rajendran⁸, Katrien Van Beneden⁶, Jacques-Eric Gottenberg⁹ and Gerd Burmester¹⁰, ¹Oregon Health & Science University, Schools of Medicine and Public Health,, Portland, OR, ²Division of Rheumatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria, Wien, Austria, ³Department of Clinical Sciences and Community Health, University of Milan, and Department of Rheumatology and Medical Sciences, ASST Gaetano Pini-CTO, Milano, Italy, ⁴University of Occupational and Environmental Health, Kitakyushu, Japan, ⁵Keio University School of Medicine and Saitama Medical University, Tokyo, Japan, ⁶Medical Safety, Galapagos NV, Mechelen, Belgium, ⁷Biostatistics, Galapagos NV, Mechelen, Belgium, ⁸Clinical Research, Galapagos NV, Mechelen, Belgium, ⁹Rheumatology Department, Strasbourg University Hospital, Strasbourg, France, ¹⁰Charité – Universitätsmedizin Berlin, Department of Rheumatology and Clinical Immunology, Berlin, Germany
Background/Purpose: Filgotinib (FIL) is an oral Janus kinase 1 preferential inhibitor, approved for the treatment of moderate to severe active rheumatoid arthritis (RA). In previous…
Abstract Number: 1441 • ACR Convergence 2023
Bimekizumab Maintenance of Response and Safety in Patients with Moderate to Severe Plaque Psoriasis: Results from the Open-label Extension Period (Weeks 48–144) of the BE RADIANT Phase 3b Trial
Bruce Strober¹, Luis Puig², Andrew Blauvelt³, Diamant Thaçi⁴, Boni Elewski⁵, Maggie Wang⁶, Veerle Vanvoorden⁷, Delphine Deherder⁸, fabienne Staelens⁸, Susanne Wiegratz⁹, Joseph F. Merola¹⁰ and Carle Paul¹¹, ¹Yale University, New Haven, CT, ²Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain, ³Oregon Medical Research Center, Portland, OR, ⁴Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany, ⁵Department of Dermatology, University Hospitals of Cleveland, Case Western Reserve University, Cleveland, OH, ⁶UCB Pharma, Morrisville, NC, ⁷UCB Pharma, Brussels, Belgium, ⁸UCB Pharma, Braine-l’Alleud, Belgium, ⁹UCB Pharma, Monheim am Rhein, Germany, ¹⁰Brigham and Women's Hospital and Harvard Medical School, Boston, MA, ¹¹Toulouse University and CHU, Toulouse, France
Background/Purpose: Clinical improvements through Week (Wk)96, with no unexpected safety findings, have previously been reported with bimekizumab (BKZ) in the BE RADIANT phase 3b trial…

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